High Court dismisses ABPI's review of new NICE rules

The UK High Court has turned down the ABPI’s application for a judicial review of NICE’s new procedures for assessing costly medicines.

The policy introduced an additional negotiation process for medicines that have already been assessed as cost-effective if they are likely to cost the NHS more than £20 million in any of the first three years of use. This means that some drugs for very rare diseases will be subject to a maximum cost threshold for the first time.

NICE has said that around one in five new medicines will be affected.

Upon applying for the judicial review, ABPI said that the new procedures could cause significant delays to patients waiting for drugs in disease areas such as cancer or diabetes, and especially those suffering from rare conditions.

However the Association’s members were divided, with UK-based GSK and AstraZeneca distancing themselves from the action.

Following the ruling, NHS England said: “In this ruling the High Court has rejected ABPI’s flawed legal manoeuvres which the judge said would ‘produce an absurd result’. Rather than attempting to further frustrate NICE and the NHS’ work to ensure patients and taxpayers get maximum value out of the £15 billion being spent on drugs, it now makes sense to work together towards that shared goal.”

In its own statement, the ABPI said it was “disappointed that the judicial review application has been turned down” but that the Board of the ABPI had unanimously agreed to accept the decision and will not appeal.

"Our concern has always been that patients should not miss out on medicines which are proven to be both clinically beneficial and cost-effective," the Association added. "Throughout this action the ABPI has maintained positive and constructive dialogue with NICE, the NHS and Government and we are encouraged that the issues are now better understood.

"Working in partnership with industry, Government and the NHS we must now focus on finding real, workable solutions to help NHS patients get fast access to the medicines they need.

"The positive reception by Government to the Life Sciences Industrial Strategy recommendations is a good start and we now look forward to seeing them fully implemented. This is best achieved through agreeing a strong sector deal that both improves access to new medicines and ensures the UK remains a successful place to research and develop medicines.”